SIMPLE T YOUTH NASAL MASK

SIMPLE T YOUTH NASAL MASK is an FDA 510(k)-cleared medical device (K140268) manufactured by Respironics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 2014. Regulation: 8.